US to widen research on stem cells from 'spare' embryos

Stem cell biologists will be able to seek US federal funding for research on dozens – maybe even hundreds – of human stem cell lines that were previously off limits, under draft guidelines issued on Friday by the National Institutes of Health (NIH). But some researchers say the guidelines are still too restrictive.

If adopted in their current form, the guidelines would allow federal funds to be used for research on human embryonic stem (ES) cells isolated from "spare" embryos from fertility clinics. These embryos are left over from attempts at reproduction through IVF.

"The guidelines will help the field move forward," says Leonard Zon, a developmental biologist at the Children's Hospital in Boston.

But some researchers are disappointed that the NIH has not gone further and opened the door to the future funding of projects involving cells taken from embryos created specifically for research – including those made by cloning. "This is a real comedown," says Irving Weissman, a stem cell biologist at Stanford University in California.

On 9 March, President Barack Obama announced that he would overturn restrictions introduced by his predecessor, George Bush, which had limited federal funding to about 20 ES cell lines isolated before August 2001. Obama left the details to be worked out by officials at the NIH, giving them 120 days to complete the process.

Ethical standards

As well as restricting funding to research on cells derived from spare fertility-clinic embryos, the draft NIH guidelines include standards to ensure that embryo donors consented to the cells' use in research and that they received no payments or other inducements.

Federal funding for attempts to create new ES cell lines would remain banned, under a law known as the Dickey-Wicker amendment.

The guidelines would also prohibit federal funding for research in which human ES cells – or reprogrammed human "induced pluripotent" stem cells, which have similar properties – are introduced into pre-implantation primate embryos, or any breeding experiment in which an animal might produce sperm or eggs derived from these human cells.

Public opinion

Many of the 700 or so lines of human ES cells that are now thought to exist would be eligible for funding under the new guidelines. "NIH is looking forward to expanding research involving human embryonic stem cells," acting NIH director Raynard Kington said in a 17 April teleconference, although he could not put an approximate figure on the number of eligible lines when pressed by New Scientist.

In deciding not to sanction federal funding for embryos created specifically for research,

In any case, he added, NIH had no knowledge of any available human ES cell lines created by IVF specifically for research: "They may be out there, but we aren't aware of them."

'Grandfathered' in

Still, several teams are now trying to isolate stem cells from human embryos created by cloning – a feat once fraudulently claimed to have been achieved by South Korea's Woo Suk Hwang. If these groups succeed, there will be a strong demand from stem cell biologists to study these cells using federal funding – which would not be allowed under the draft guidelines.

The other main concern of researchers is that some of the small number of ES cell lines currently eligible for federal funding may not meet the strict standards for informed consent laid down in the draft guidelines. To prevent existing avenues of research being shut down, says Kevin Wilson of the American Society for Cell Biology, it may be necessary to allow some older cell lines to be "grandfathered" onto the list eligible for funding.

After the guidelines are published in the Federal Register next week, there will be 30 days during which people can suggest changes. The final guidelines will be published by 7 July.

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